Intended Use
Testosterone iCLIA Kit is intended for the in vitro quantitative measurement of testosterone in human serum/plasma, as an aid in the diagnosis of diseases related to abnormal testosterone level in conjunction with other laboratory and clinical findings. This kit is only operational in conjunction with J. Mitra CLIA Analyzer.
Salient Features
- Based on Competitive chemiluminescent microparticle immunoassay
- Acridinium Ester (AE) based kit for more accurate results
- Test result within 30 minutes
- Analytical Sensitivity: 1 ng/ml
- Linearity: 1 ng/ml to 20 ng/ml
- Long shelf life: 12 months at 2-8oC
- Onboard stability of reagents: 30 days at 2-8oC
- Convenient pack size: 50 Tests
- Prompt service back-up
Principle
Testosterone iClia is a “Competitive immunoassay” using microparticle acridinium ester chemiluminescent technology.
In the first step, anti-Testosterone antibody labelled magnetic microparticle and human serum/ plasma are mixed and incubated in an assay tube. In the Next step, AE Conjugate (Testosterone conjugated acridinium ester) is added and combined, AE labelled Testosterone and Testosterone in sample compete for the binding site of Testosterone antibody on the binding magnetic particle, and the Microparticle- Testosterone antibody/ Testosterone immune complex is kept with the help of a magnetic separator. Unbound acridinium ester and other substance are removed by washing and finally the bound enzyme is detected by addition of chemiluminescent substrate. Pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). The relative light unit (RLU) intensity is inversely proportional to the amount of Testosterone in the sample. Results are calculated automatically based on the established calibration curve and concentration of Testosterone in the sample is expressed as ng/ml.
